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CTRI Number  CTRI/2013/09/003965 [Registered on: 10/09/2013] Trial Registered Retrospectively
Last Modified On: 23/08/2013
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   DESCRIPTIVE PROSPECTIVE STUDY 
Study Design  Other 
Public Title of Study   ROLE OF BLOOD LEVELS OF URIC ACID,C-REACTIVE PROTEIN AND TROPONIN-T IN HEART DISEASE. 
Scientific Title of Study   Role of Serum Uric Acid ,C-reactive Protein and troponin T as Prognostic Indicators in patients of Acute Coronary Syndrome. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrHIREMATH SOURAB 
Designation  POST GRADUATE RESIDENT 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  Dr.HIREMATH SOURAB, DEPARTMENT OF GENERAL MEDICINE, FATHER MULLER MEDICAL COLLEGE, KANKANADY,MANGALORE
Dr.HIREMATH SOURAB,PLOT NO:999 VANTAMURI COLONY, MM EXTENSION, BELGAUM-590016
Belgaum
KARNATAKA
575002
India 
Phone  7829726532  
Fax    
Email  drsourabmd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Col R Arunachalam 
Designation  professor in medicine 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  DEPARTMENT OF GENERAL MEDICINE, FATHER MULLER MEDICAL COLLEGE, KANKANADY,MANGALORE

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9481846382  
Fax    
Email  arunachalam14759@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DrHIREMATH SOURAB 
Designation  POST GRADUATE RESIDENT 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  Dr.HIREMATH SOURAB, DEPARTMENT OF GENERAL MEDICINE, FATHER MULLER MEDICAL COLLEGE, KANKANADY,MANGALORE
Dr.HIREMATH SOURAB,PLOT NO:999 VANTAMURI COLONY, MM EXTENSION, BELGAUM-590016
Belgaum
KARNATAKA
575002
India 
Phone  7829726532  
Fax    
Email  drsourabmd@gmail.com  
 
Source of Monetary or Material Support  
FATHER MULLER MEDICAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  FATHER MULLER MEDICAL COLLEGE 
Address  DEPARTMENT OF GENERAL MEDICINE, FATHER MULLER MEDICAL COLLEGE, KANKANADY,MANGALORE 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrHIREMATH SOURAB  FATHER MULLER MEDICAL COLLEGE AND HOSPITAL  DEPARTMENT OF MEDICINE,FATHER MULLER MEDICAL COLLEGE AND HOSPITAL, KANKANADY, MANGALORE
Dakshina Kannada
KARNATAKA 
7829726532

drsourabmd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  40 PATIENTS WITH ACUTE CORONARY SYNDROME,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)Age greater than or equal to 18 years.
(2)Patients with first episode of Acute Coronary Syndrome.
 
 
ExclusionCriteria 
Details  1)Patients with chronic kidney disease.
(2) Gout, haematological malignancy ,hypothyroidism, patients on drugs raising uric acid level.
(3)Patients in sepsis.
(4) Patients suffering from connective tissue disorders.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
EXPECTED CHANGES IN SERUM PARAMETERS.  EXPECTED CHANGES IN SERUM PARAMETERS. 
 
Secondary Outcome  
Outcome  TimePoints 
Serum Uric Acid ,C-reactive Protein and troponin T as Prognostic Indicators in patients of Acute Coronary Syndrome.  Serum Uric Acid ,C-reactive Protein and troponin T as Prognostic Indicators in patients of Acute Coronary Syndrome. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/11/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Brief resume of the work

6.1 Need for the study

   Cardiovascular disease is responsible for 30% of all deaths in the world.  About 80% of the global burden of CVD  deaths occur in low and middle income countries. India carries a significant portion of this CVD burden .India suffers one of the highest CVD case fatality rates in the world according to an international registry (OASIS) comparing the outcome among patients of Acute Coronary Syndrome.(1)

    Until now various bio-markers have been studied in patients of Acute coronary syndrome. However, no single marker gives definite prognostic information during the course of the disease. Little information is available about the role of different individual bio markers .Hence a comparative study is attempted using 3 easily measured ,broadly available bio-markers namely serum Uric Acid, troponin-T and C reactive protein targeting different risk indicators like purine metabolism, cardiac myocyte injury and inflammation.

Acute coronary Syndrome encompasses MI(STEMI and NSTEMI) and Unstable Angina .

Diagnostic criteria (2) (3)

1.      Chest discomfort (with or without radiation to the arms, back , neck jaw or epigastrium) or anginal equivalents such as shortness of breath, diaphoresis or extreme fatigue.

  2. 12 lead ECG with ST segment elevation in STEMI and ST   segment  depression or prominent T wave inversion or absence of ST segment Elevation with positive biomarkers of necrosis(troponin T) for NSTEMI

      3. Elevated cardiac bio markers like troponin-T.

 

6.2 Review of Literature

    1. Peter A. Kasak and group measured CRP in 446 emergency department patients with acute coronary syndromes. All-cause mortality and hospital discharges for acute myocardial infarction and congestive heart failure were obtained for period of eight years following the event. Kaplan-Meier analyses indicated that the patients with CRP concentrations above the American Heart Association scientific statement cut off 10 mg/ml had a higher rate of death and CHF admissions .Study concluded that patients presenting early with chest pain with elevated CRP concentrations have a greater long term risk for death and heart failure.(4)

2. MY Nadkar and V I Jain studied 100 patients with acute myocardial infarction and 50 controls. Serum uric acid level was measured on day 0,3 and 7 of MI. On all the days serum uric acid levels were higher in patients who were in higher Killip class. Study concluded that serum uric acid levels are higher in patients of acute myocardial infarction correlated with Killip classification.(5)

3. S.M.N.A Nadeem K and group studied 255 consecutive patients admitted with diagnosis of unstable angina and non STEMI . All patients had a baseline troponin T estimation done and repeated twelve hours later in case of an initial negative result. . Study concluded that positive troponin T in patients with UA/NSTEMI is a strong , independent risk predictor of future death and MI.(6)

6.3 Objective of the study:

To assess the role of Serum uric acid , C-reactive protein and troponin T as best prognostic indicator in patients of Acute Coronary syndrome  admitted in Father Muller Medical College Hospital.

 

Materials and Methods

7.1 Source of data:

The data will be collected from patients admitted in Father Muller’s Medical College Hospital with acute coronary syndrome  from 1st August 2011 to 1st August 2012.

7.2. Method of collection of data:

  STUDY DESIGN

The study will be a descriptive prospective study of the patients admitted in Father Muller’s Medical College with Acute coronary syndrome

The study will include a minimum of 40 patients diagnosed with acute coronary syndrome .Three bio markers namely troponin-T, serum Uric acid and CRP will be measured on day 0 .Troponin t will be measured by Dry Chemistry (turbidimetric method) and will be repeated after twelve hours if initially found negative, Uric acid by Uricase method and CRP by turbidimetric method. Patients will be followed up over a period of seven days. Death ,Heart failure(Killip class I to IV), recurrent ACS and LV ejection fraction will be taken as end points of the study . All the values will be statistically compared to determine a single bio marker predicting the prognosis.

Inclusion Criteria

(1)Age greater than or equal to 18 years.

(2)Patients with first episode of Acute Coronary Syndrome.

Exclusion Criteria

(1)Patients with chronic kidney disease.

(2) Gout, haematological malignancy ,hypothyroidism, patients on drugs raising uric acid level.

(3)Patients in sepsis.

(4) Patients suffering from connective tissue disorders.

Data Analysis: Data will be analyzed by frequency , percentage , mean, standard deviation, ANOVA and Chi-Square.

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals?

     YES

     The following investigations will be done

 Routine blood investigations- Haemoglobin, total cell count and differential count.

Urine  microscopy, serum creatinine.

 ECG , 2 D ECHO , troponin -T, Serum Uric acid and CRP.


 

 

 
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